Multicapsule intraluminal grafting system and method

ABSTRACT

An intraluminal grafting system having a balloon catheter assembly, a capsule catheter assembly and capsule jacket assembly is used for deploying a graft having attachment means in the vessel of an animal body. The system contains a proximal capsule means and a distal capsule means, wherein the graft is disposed within the two capsule means and a removable sheath covers the graft and capsule means. The graft is comprised of a tubular member having superior and inferior ends, having attachment means with wall engaging members secured thereto. The balloon catheter is disposed within the capsule catheter to provide relative movement between the balloon catheter and the capsule catheter, whereby the graft can be removed from the capsule means. The balloon is inflated to firmly implant the graft and attachment means within the vessel. The graft and attachment means remain in the vessel after the intraluminal grafting system is withdrawn.

This application is a continuation of application Ser. No. 08/102,576filed Aug. 5, 1993 now abandoned, which is continuation-in-part ofapplication Ser. No. 07/553,530 filed on Jul. 13, 1990, now U.S. Pat.No. 5,275,622, which is a continuation-in-part of application Ser. No.07/166,093 filed on Mar. 9, 1988, now U.S. Pat. No. 5,104,399, which isa continuation-in-part of application Ser. No. 07/940,907 filed on Dec.10, 1986, now U.S. Pat. No. 4,787,899 which is a continuation ofapplication Ser. No. 06/559,935 filed on. Dec. 9, 1983, now abandoned.The contents of each of these applications are hereby incorporated byreference.

BACKGROUND OF THE INVENTION

This invention relates to a system for emplacing a prosthesis and, moreparticularly, to a catheter system for placement of a graft havingattachment means within a corporeal lumen.

It is well established that various fluid conducting body or corporeallumens, such as veins and arteries, may deteriorate or suffer trauma sothat repair is necessary. For example, various types of aneurysms orother deteriorative diseases may affect the ability of the lumen toconduct fluids and in turn may be life-threatening. In some cases, thedamaged lumen is repairable only with the use of prosthesis such as anartificial vessel or graft.

For repair of vital vessels such as the aorta, surgical repair issignificantly life-threatening. Surgical techniques known in the artinvolve major surgery in which a graft resembling the natural vessel isspliced into the diseased or obstructed section of the natural vessel.Known procedures include surgically removing or bypassing the damaged ordiseased portion of the vessel and inserting an artificial or donorgraft inserted and stitched to the ends of the vessel which were createdby the removal of the diseased portion.

It is known within the art to provide a prothesis for intraluminalrepair of a vessel, such as an abdominal aorta having an aneurysm. Theart has taught to provide a prothesis positioned in a vessel thensecuring the prothesis within the vessel with hooks or staples that aremechanically extended by the user. The early prior art devices werelarge in diameter, mechanically complex and in turn were susceptible tomechanical failure. Prior intraluminal grafting systems have embodiedcapsule catheters or balloon catheters, but were relatively stiff and ofa relatively high profile. Similarly, the prior art systems wereconfigured in such a way that the graft was relatively difficult todeploy the prothesis. In addition, prior systems having capsule cathetermeans were usually configured such that the prothesis was disposedwithin a unitary capsule.

In recent years, several devices have been developed to attempt to treatan aortic aneurysm through intraluminal repair. For example, U.S. Pat.No. 4,140,126 (Feb. 20, 1979), Choudhury, discloses a method and articlefor performing an aneurysm repair, wherein a prosthetic graft isutilized to replace the damaged segment of the blood vessel. A pluralityof radially spaced anchoring pins are located adjacent each end of thegraft and provide means for securing the graft to the wall of thevessel. Means is provided for moving the graft within the vessel andpermanently anchoring the graft to the wall of the vessel.

U.S. Pat. No. 4,562,596 (Jan. 7, 1986), Kornberg, discloses a bifurcatedaortic graft constructed for intraluminal insertion having a pluralityof struts having angled hooks with barbs at their superior ends. Meansfor inserting the graft and implanting the hooks into the vessel lumenis also disclosed.

U.S. Pat. No. 4,787,899 (Nov. 29, 1988), Lazarus, discloses anintraluminal grafting system including a hollow graft having anattachment means located at one end of the graft. The system includespositioning means for moving the graft within the vessel, thepositioning means having a capsule positioned at one end for coveringthe graft attachment means. The disclosed positioning means furtherincludes an inflatable member for securing the attachment means withinthe lumen.

EPO Pub. No. 0 461 791 A1 (Dec. 18, 1991), Barone et al. discloses anaortic graft and apparatus for repairing an aneurism. The disclosedsystem includes a tube graft secured within the aorta and an attachmentmeans at each end of the graft. Intraluminal delivery is accomplishedusing a catheter having a balloon for expanding and securing theattachment means. The graft and attachment means are preferably enclosedby a sheath which covers the entire graft and attachment means.

EPO Pub. No. 0 466 518 A3 (Jan. 15, 1992), Lazarus et al., discloses anintraluminal grafting system including a catheter having a capsuleformed of a helical wrap of metal ribbon. A tubular graft havingattachment means at both ends is removably disposed within the capsule.Means is provided for moving the graft from the capsule, and aninflatable member is provided for securing the attachment means within avessel lumen.

U.S. Patent No. 5,104,399 (Apr. 14, 1992), Lazarus, discloses anintraluminal grafting system including a tubular graft having attachmentmeans positioned at both ends. The system includes a positioning meansfor transporting the graft through a vessel lumen and for deploying thegraft within the lumen. The positioning means includes an inflatablemember, a capsule and means for removing the graft from the capsule. Thecapsule is disclosed as a rigid cylindrical member covering the entiregraft.

EPO Pub. No. 0 508 473 A2 (Oct. 14, 1992), Piplani et al., discloses anintraluminal grafting system including a catheter having a capsuleformed of a helical wrap of metal ribbon. A bifurcated graft havingattachment means is removably disposed within the capsule. Means isprovided for moving the graft from the capsule, and an inflatable memberis provided for securing the attachment means within a vessel lumen.

The foregoing patents and publications are incorporated herein byreference.

To provide consistency with the common usage of terms used in themedical surgical arts in the United States, the terms "proximal, distal,inferior and superior" are used with a certain regularity within thepresent specification. Proximal refers to parts of the system, such ascatheters, capsules and wires, which are closest to the user and closestto the portion of the system outside or exterior of the patient. Distalrefers to the point farthest from the user and typically most interiorto the corporeal lumen. The term superior refers to a location situatedabove and is used herein in description of the graft and attachmentmeans. Inferior refers to the point situated below and again is usedherein with the graft and attachment means. Thus, for applications inthe abdominal aorta which use a femoral approach, the superior end ofthe graft resides within the most distal portion of the ballooncatheter. Likewise, the inferior end of the graft resides within theproximal capsule which is on the most distal portion of the capsulecatheter.

SUMMARY OF THE INVENTION

In general, it is an object of the present invention to provide anintraluminal grafting system and method which overcome the disadvantagesof the prior art systems.

The present system has several advantages over prior art systems. Forexample, the over the wire configuration of the balloon catheter enablestraversing the aneurysm with a guidewire. Using a guidewire in thismanner minimizes the risk of dislodging thrombus in the aneurysm, sincethe placement means follows the guidewire thereby preventing the distaltip from contacting the vessel wall. In addition, using a guidewireallows for traversing more difficult anatomy. Also, the guide wire lumenmay function as a through lumen for real time angiograms during theemplacement procedure or to insert intravascular probes such asintravascular ultrasound systems.

As another advantage, the smaller diameter and lower profile of thecapsule assemblies of the present invention permit use of the inventionin a larger patient population because the variances in iliac vesseldiameter. Similarly, the smaller device diameter relative to the iliacdiameter may allow for easier navigation inside the corporeal lumenespecially with more difficult anatomy. Likewise, the two capsulesegments of the present invention permit a wider range of graft lengthsthan available with a single capsule design. The single capsule systemsalso require capsules slightly longer than the graft, which imposescertain manufacturing and deployment problems. Moreover, the shortercapsule segments provide a more flexible device, thereby allowingtraversing more difficult anatomy.

The present invention comprises an intraluminal placement means forsecuring a prothesis within or between vessels or corporeal lumens of ananimal, such as a human. The preferred embodiment of the placement meansis configured for introducing a graft into a corporeal lumen andpositioning the graft in the area of the aortic bifrucation. Theplacement means includes a balloon catheter, a capsule catheter and acapsule jacket. In the preferred embodiment, the balloon catheter andcapsule catheter include capsule means for retaining the graft,including a proximal capsule means and a distal capsule means. Thecapsule means are movable relative to each other to allow the graft tobe emplaced at the desired location in the corporeal lumen.

Preferably, the placement means includes a balloon catheter having amultilumen hollow tube or shaft having a proximal end provided withmeans for accepting a guide wire and with means for inflating a balloonor similar inflatable member. The balloon catheter shaft is ofsufficient length that the proximal end remains exterior the corporeallumen while the distal end of the balloon catheter shaft may bepositioned proximate the portion of the corporeal lumen to be repaired.The balloon catheter further has means for inflating and deflating theballoon. In addition, the balloon catheter is coupled to control meansand a distal capsule for retaining and releasing the superior end of thegraft. In the preferred embodiment, the control means includes a controlwire and handle mechanism which provides movement of the distal capsulerelative to the balloon catheter shaft.

The placement means also includes a capsule catheter shaped and sizedfor positioning within the corporeal lumen. The capsule cathetercomprises a hollow tube or shaft slidably mounted on the ballooncatheter shaft, having a proximal end exterior the corporeal lumen formanipulation by the user. The capsule catheter includes a proximalcapsule secured to the distal end of the capsule catheter shaft forretaining the inferior end of the graft. The placement means isconfigured to provide relative movement between the proximal capsule ofthe capsule catheter and the distal capsule of the balloon catheter forremoving the graft from the capsule means and for subsequently urgingthe attachment means into engagement with the wall of the corporeallumen.

The placement means further includes a capsule jacket for providing asmooth transition between the parts of the balloon catheter and capsulecatheter. The capsule jacket comprises a double walled jacket or sheathconfigured coaxially with the balloon catheter and capsule catheter,having a proximal end exterior the corporeal lumen for manipulation bythe user. The distal end of the capsule jacket flares outwardly to asize which is slidably retained over the distal capsule when theplacement means in deployed into the corporeal lumen.

The present invention includes a prosthesis or graft for intraluminalplacement in a fluid conducting corporeal lumen. For most applicationsthe prothesis is a hollow graft of preselected cross-section and length.The graft is deformable to conform substantially to the interior surfaceof the corporeal lumen or other body part to be repaired. Preferably,the graft is made of a material suitable for permanent placement in thebody such as polytetrafluroethylene or a polyester. During emplacement,the superior and inferior ends of the graft are positioned within thecorporeal lumen and the graft is configured such that the grafttraverses the diseased or damaged portion of the vessel. To anchor thegraft to the wall of the corporeal lumen, attachment means are securedto the superior and inferior ends of the graft.

The preferred attachment means has wall engaging members. The wallengaging members of the superior attachment means are angled toward theinferior end of the graft. Similarly, the wall engaging members of theinferior attachment means are angled slightly toward the superior end ofthe graft. The wall engaging members of both attachment means have sharptips for engaging the corporeal lumen wall. The preferred attachmentmeans are formed into a V-shaped lattice or framework. The frame of theattachment means allows for elastic radial deformation resulting in aspring-like effect when a compressed attachment means is allowed toexpand as the graft is released from the capsule means. In addition,radiopaque markers are secured to the longitudinal axis of the graft tofacilitate orientation of the graft using fluoroscopy or x-raytechniques.

Deployment of the graft comprises a series of steps which begins withintroducing the placement means into the corporeal lumen using wellknown surgical techniques. As a single system, the balloon catheter,capsule catheter and capsule jacket are manipulated to position thecapsule means containing the graft and attachment means to a desiredlocation within the corporeal lumen. Once the graft is in the desiredlocation, the capsule jacket is withdrawn to expose the distal capsuleand a portion of the graft. The distal capsule is then moved relative tothe balloon catheter shaft and capsule catheter to expose the superiorattachment means.

After the superior portion of the graft is removed from the capsulemeans, the inflatable member is moved to within the circumference of thesuperior attachment means and inflated to urge wall engaging membersinto the wall of the corporeal lumen. The capsule jacket and capsulecatheter are then moved relative to the graft and balloon catheter shaftto expose the inferior attachment means. The balloon catheter shaft isthen moved to position the inflatable member proximate the inferiorattachment means. The inflatable member is then expanded to seat thewall engaging members of the inferior attachment means. The placementmeans is then removed from the corporeal lumen.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of an intraluminal grafting apparatus andsystem incorporating the present invention.

FIG. 2 is a top plan view of a guidewire to be used with theendovascular grafting system of the present invention.

FIG. 3 is a top plan view of the balloon catheter of the presentinvention.

FIG. 4 is a top plan view of the distal cap, control wire, guiding tubeand control wire handle assembly of the present invention.

FIG. 5 is a top plan view of the proximal capsule and capsule catheterassembly of the present invention.

FIG. 6 is a top plan view of the capsule jacket assembly of the presentinvention.

FIG. 7 is a top plan view of a graft for use with the systemincorporating the present invention.

FIG. 8 is a partial cross-sectional view of the distal end of theballoon catheter, capsule catheter and capsule jacket assemblies takenalong the line 8--8 of FIG. 1.

FIG. 9 is an enlarged perspective view showing an embodiment of thedistal capsule, distal end of the control wire and distal cap insert.

FIG. 10 is an enlarged cross-sectional view of one embodiment of thedistal capsule means of the balloon catheter.

FIG. 11 is a cross-sectional view taken along the line 11--11 of FIG.10.

FIG. 12 is an enlarged perspective view showing an embodiment of thedistal capsule, distal end of the control wire and distal cap insert.

FIG. 13 is an enlarged cross-sectional view of an embodiment of thedistal capsule means of the balloon catheter.

FIG. 14 is a cross-sectional view taken along the line 14--14 of FIG.13.

FIG. 15 is a partial cross-sectional view of the control wire andcontrol handle mechanism taken along the line 15--15 of FIG. 1.

FIG. 16 is a cross-sectional view taken along the line 16--16 of FIG.15.

FIG. 17 is a cross-sectional view taken along the line 17--17 of FIG.15.

FIG. 18 is a cross-sectional view taken along the line 18--18 of FIG. 1.

FIG. 19 is a cross-sectional view taken along the line 19--19 of FIG. 1.

FIG. 20 is a cross-sectional view taken along the line 20--20 of FIG. 1.

FIG. 21 is a cross-sectional view taken along the line 21--21 of FIG. 1.

FIG. 22 is a cross-sectional view taken along the line 22--22 of FIG. 1.

FIG. 23 is a partial cross-sectional view of the graft and attachmentmeans of the present invention.

FIG. 24 is a cross-sectional view taken along the line 24--24 of FIG.23.

FIG. 25 is an enlarged perspective view showing a superior attachmentmeans.

FIG. 26 is an enlarged perspective view showing an inferior attachmentmeans.

FIG. 27 is a partial cross-sectional view of the intraluminal graftingsystem shown positioned within the corporeal lumen.

FIG. 28 is a partial cross-sectional view of the intraluminal graftingsystem, wherein the distal capsule has been removed from the superiorend of the graft.

FIG. 29 is a partial cross-section view of the intraluminal graftingsystem, wherein the inflatable member has been expanded to seat theattachment means of the graft.

FIG. 30 is a partial cross-sectional view of the intraluminal graftingsystem, wherein the capsule jacket and capsule catheter have beenwithdrawn from the inferior end of the graft.

FIG. 31 is a partial cross-sectional view of the intraluminal graftingsystem, wherein the inflatable member has been positioned and inflatedto seat the inferior attachment means.

FIG. 32 is a partial cross-sectional view of the intraluminal graftingsystem, wherein the inflatable member has been moved proximate theproximal capsule.

FIG. 33 is a partial cross-sectional view of the intraluminal graftingsystem, wherein the balloon catheter, capsule catheter and capsulejacket have been placed in a position for withdrawal from the corporeallumen.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings and for purposes of illustration, the inventionis embodied in an intraluminal grafting system of the type having aballoon catheter, a capsule catheter, and a protective sleeve or capsulejacket. One of the novel features of the present system is the use of aproximal capsule and a distal capsule to cover the inferior and superiorends of a graft to be implanted in the vessel. This feature provides thecapability of deploying the interior end of the graft before thesuperior end or visa versa. Another novel feature of the presentinvention is the use of a sleeve or capsule jacket to create a smoothtransition between the proximal capsule and the distal capsule. Theuniqueness of the system is accentuated by the control wire andassociated handle which provide relative movement between the distalcapsule and the balloon catheter.

In the present system, the graft is comprised of a monoluminal tubularmember having superior and inferior extremities. Attachment means aresecured to the superior and inferior ends of the tubular member. Theattachment means are provided with lumen piercing means which arecovered by the proximal and distal capsule assemblies. The ballooncatheter, capsule catheter and capsule jacket are configured coaxiallyso that relative movement between them provides for deployment of thegraft. The inflatable member of the balloon catheter is used to firmlyimplant the graft in the lumen.

In more detail, the intraluminal grafting system 50 is shown in FIGS.1-7. As shown in FIG. 1, the system includes a balloon catheter assembly51, which is coaxially disposed within capsule catheter assembly 52,which is coaxially disposed within capsule jacket assembly 53. Thecapsule catheter and a distal capsule catheter assembly 90 are used tocontain the graft 55. A control wire assembly 54 is coaxially disposedwithin a lumen of the balloon catheter assembly and configured to movethe distal capsule assembly in relation to the other system components.In the preferred embodiment, the system is used as an over-the-wiredevice, such that the balloon catheter is further configured with alumen for a guide wire 56. It is contemplated, however, that the systemcan also be used with well known fixed wire delivery systemconfigurations.

As shown in FIGS. 1 and 3, the intraluminal grafting system 50 alsoincludes a balloon catheter assembly 51 which consists of an inflatablemember or balloon 60 secured to a flexible elongate element or ballooncatheter shaft 61. As shown in FIG. 18, the balloon catheter shaft ispreferably configured with three lumens; however, the balloon cathetermay be configured with a single, dual or similar multilumen shaft. Aguide wire lumen 63 extends the length of the balloon catheter shaft.Similarly, a balloon inflation lumen 64 extends from the proximal end 70of the balloon catheter to the inflatable member 60, wherein aninflation port 83, FIG. 8, is provided to allow inflation fluid to enterand exit the inflatable member. The third lumen 65 is provided for thecontrol wire assembly 54.

The flexible elongate element or balloon catheter shaft 61 is preferablyformed of a material suitable for intraluminal use, such as irradiatedpolyethylene tubing. The three lumen balloon catheter shaft ispreferably extruded to an outside diameter of 0.08 inches (2.03 mm). Theguide wire lumen 63 has an inner diameter of 0.042 inches (1.07 mm). Theinflation lumen 64 and the control wire lumen 65 have identical innerdiameters of 0.022 inches (0.56 mm). However, the lumen inside diametermay range from 0.015 to 0.06 inches (0.381-1.52 mm) and the outsidediameter may range from 0.035 to 0.1 inches (0.889-2.54 mm) for amultilumen balloon catheter shaft. The balloon catheter may vary inlength to suit the application, for example, from fifty to onehundred-fifty centimeters.

Referring to FIG. 1, the proximal extremity 70 of the balloon cathetershaft 61 is secured to a splitting adapter 71 which splits the guidewire lumen 63 from inflation lumen 64. The side arm 72 of the adapter 71has a stop cock 73 mounted at its proximal end which is movable betweenopen and closed positions. The stop cock is provided with a Luer fitting74 which is adapted to be secured to a syringe for injecting inflationfluid. The side arm 75 of the adapter 71 is connected to female Luerfitting 77 for distal tip injection and to a Touhy Borst adapter 76which is configured to removably and slidably receive the guide wire 56.

The inflatable member or balloon 60 is preferably secured twelvecentimeters from the distal extremity 80 of the balloon catheter shaft61. The balloon is positioned proximal of the distal capsule assembly 90and the superior end of the graft 55. For shorter grafts of four toseven centimeters in length, the inflatable member may be positioneddistal of the distal capsule assembly. The balloon is formed of suitablematerial such as polyethylene. The balloon can vary in diameter fromtwelve to forty-five millimeters in diameter and can have a wallthickness ranging from 0.001 to 0.005 inches (0.0254-0.127 mm). Thepolyethylene utilized for the balloon is irradiated to achieve anappropriate balloon size. The preferred balloon made in accordance withthe present invention has an outside diameter of twenty-fourmillimeters, a diameter equal to the inner diameter of the graft, andhad a wall thickness of approximately 0.003 inches (0.076 mm). Inaddition, the balloon is pleated along its axis for a low profile whichfacilitates its introduction into a corporeal lumen of a patient ashereinafter described. Further, the deflated balloon is heated toprovide it with a memory of its low profile configuration.

Balloon catheter shaft 61 is provided with an inflation lumen 64 whichis in fluid communication with the inflation port 74. The inflationlumen is used to inflate and deflate the balloon 60 by introducing andwithdrawing a gas or liquid through the inflation port. The balloon issecured approximately twelve centimeters from the distal extremity 80 ofthe balloon catheter shaft. The balloon proximal stem 81 and balloondistal stem 82 are heat sealed to the balloon catheter shaft to form afluid tight seal. The length of the proximal stem may vary from 0.5 to5.0 centimeters so that the balloon will span the distance between theinferior and superior attachment means of the graft 55.

The balloon catheter shaft 61 has an inflation port 83 locatedapproximately ten millimeters distal the balloon proximal stem 81. Inaddition, a radiopaque marker 84 is embedded in the balloon cathetershaft approximately two millimeters distal the balloon inflation port.Preferably, the radiopaque marker is a platinum or tungsten coil onecentimeter long with an outer diameter of 0.02 inches (0.508 mm) and islocated proximate the center of the balloon 60. It should be appreciatedthat although a separate inflatable member has been described in thedrawing, an integral coaxial inflatable member may be provided which isformed of the same tubing from which the balloon catheter shaft is made.This can be readily accomplished, as is well known to those skilled inthe art, by using an additional radiation dose for the balloon region ofthe shaft.

As shown in FIGS. 2 and 8, a pusher button 85 is slidably mounted on theballoon catheter shaft 61 and is located proximal the balloon proximalstem 81, for example, a distance of five to eight centimeters. Thepusher button is retained from moving proximal on the shaft by anannular bulb 86 which is formed by localized heating of the shaft. Aradiological marker band 87 is placed on the shaft just proximal theannular bulb. The pusher button is preferably cylindrical having apreferred outside diameter of 0.22 inches (5.588 mm), ranging from 0.15to 0.25 inches (3.81-6.35 mm). The pusher button is formed of a suitablematerial such as 300 series stainless steel to achieve radiopacity.

The balloon itself can also be observed under x-rays because the bloodin the patient's vessel is more opaque than the gas used for inflatingthe balloon. In addition, increased visibility of the balloon can beobtained by inflating the balloon with a diluted radiopaque contrastsolution. In addition, radiopaque bands of a suitable material such asplatinum or a platinum-tungsten alloy can be placed on the proximal anddistal balloon stems 81 and 82 to aid in ascertaining the position ofthe balloon. Similarly, radiopaque rods may be inserted in the distalballoon shaft tubing, in the control wire or balloon inflation lumens.

The intraluminal grafting apparatus also includes a control wireassembly 54, which is shown in FIGS. 1 and 4. The distal end of thecontrol wire assembly consists of a distal capsule assembly 90. As shownin more detail in FIGS. 9-14, the distal capsule assembly comprises acontrol wire 91 secured within a distal cap 92. A hollow distal capsule93 is secured to the distal cap and coaxially surrounds the controlwire.

The control wire 91 is threaded through aperture 94 in the ballooncatheter shaft 61 and is slidably disposed in the balloon catheter shaftlumen 65. Distal end 95 of the control wire is embedded in distal capinsert 96 which is secured to the distal cap 92 by means of an adhesive,solvent bonding, ultrasonic welding or by heat shrinking. As shown inFIG. 9, the distal cap insert is formed with radiopaque markers 97 and98. Preferably, a 0.04 inch (1.01 mm) wide, 0.005 inch (0.127 mm) thickand 2 millimeters long ribbon is disposed in slots formed in thecircumference of the insert at a 90 degree angle from the control wire.

As shown in FIG. 10, balloon catheter proximal cap 100 is secured to theballoon catheter shaft 61 at a position distal the balloon distal stem82 and proximal the aperture 95. The proximal cap is secured to theballoon catheter shaft by adhesive and by means of a retaining bump 101.Retaining sleeve 102 slidably secures the control wire 91 against theballoon catheter shaft. Thus, as the control wire is moved in alongitudinal manner, the distal end of the control wire 95, distal capinsert 96, the distal cap 92 and distal capsule 93 each move as a singleassembly. The proximal edges 103 of the distal capsule are rolled,curved or crimped inward so that the proximal cap will lock into thedistal capsule when the distal capsule is advanced.

Referring to FIG. 11, the distal cap 92 may be formed from polycarbonateor other suitable material for insertion through the body lumen. Thedistal cap is formed with a bore 104 of approximately the same diameteras the outer diameter of balloon catheter shaft 61. Similarly, thedistal cap insert 96 may be formed of the same material as the distalcap, wherein the distal cap insert is provided with a bore 105 forreceiving the balloon catheter shaft. The distal cap is further providedwith a recess 106 or other means for receiving the distal end of thedistal capsule 93. The distal capsule is preferably formed of stainlesssteel, but may be formed of other suitable biocompatable material, suchas a nickel titanium. The distal cap recess is angled to allow crimpingof the distal capsule to the distal cap.

The outside diameter of the distal cap 92 and capsule 93 may range from4 to 9 millimeters and is preferably 0.282 inches (7.16 mm) in outerdiameter and 0.276 inches (7.01 mm) inner diameter. Similarly, theballoon catheter proximal cap 100 outer diameter is comprised ofstainless steel and has an outside diameter slightly less that of thedistal capsule so as to provide a smooth transition. The proximal end ofthe proximal cap is preferably rounded to minimize trauma in the vesseland to facilitate balloon retraction into the graft 55 during theemplacement process. The distal capsule may range in length from one tofive centimeters, and preferably is three centimeters long so as toadequately retain the distal end of the graft 55.

FIGS. 12-14 show an alternative and embodiment of the distal capassembly 90. In this embodiment, the core wire 91 is threaded through anopening 107 in the distal cap insert 108. A longitudinal slot 109 is cutout in the balloon catheter shaft 61 to expose the core wire lumen 65.The control wire is formed in a U-shaped bend over the opening in thedistal cap insert and is configured to slide within the slot and thecore wire lumen of the balloon catheter shaft. The distal end of thecontrol wire resides in the portion of the core wire lumen beyond theend of the slot. This configuration allows the distal cap assembly tomove axially along the balloon catheter shaft. The U-shaped bend of thecontrol wire through the distal cap insert, however, prevents the distalcap assembly from rotating in relation to the balloon catheter shaft. Asdescribed above, the balloon catheter insert is firmly secured withinthe distal cap. To prevent rotation of the distal cap, a threecentimeter length of the control wire extends distal of the distal capand is slidably disposed in the balloon catheter shaft lumen 65.

As shown in FIGS. 15-17, a handle assembly 110 is secured to theproximal end of the control wire 91. The handle assembly comprises aproximal body 111, a distal body 112, a control knob 113 with threadedshaft 114 and a guiding member 115. The two handle body parts have acentral bore for receiving the balloon catheter shaft 61. The guidingmember is coaxially disposed over the balloon catheter shaft and extendsdistally from the central bore in the distal handle body. The proximalend of the guiding member is secured to the balloon catheter shaftapproximately one centimeter proximal from the distal end of the distalhandle body by means of a polyethylene sealing tube 116 which is heatshrunk over the proximal end of the guiding member. An adhesive may beused to fix the distal handle body to the guiding member.

Guiding member 115 consists of a rigid thin wall tube formed of asuitable material such as stainless steel, e.g., a catheter hypotube.The guiding member has a length of about 45 centimeters and has anoutside diameter of 0.095 inches (2.41 mm) and an inside diameter of0.087 inches (2.21 mm). The control wire 91 preferably consists of anelongate solid flexible stainless steel wire having a FEP or lubricatingcoating. The coated control wire is about 0.02 inches (0.508 mm) indiameter so as to provide sufficient strength to move the distal capsuleassembly 90 without breaking or kinking. Referring to FIG. 15, thecontrol wire resides in the balloon catheter lumen 65 and extends fromthe distal capsule assembly to an aperture 117 located in the lumen justproximal of the proximal end of the guiding member.

The proximal end of the control wire 91 is disposed within alongitudinal central bore in a retaining tube 120 approximately sixcentimeters long. The retaining tube's proximal end is slidably disposedwithin a longitudinal guiding slot 121 in proximal handle body 111.Similarly, the retaining tube's distal end is slidably disposed withinan longitudinal upper slot 122 in the distal handle body 112. Atransverse threaded bore 123 is located approximately 0.25 inches (6.35mm) from the proximal end of the retaining tube for receiving thethreaded shaft 114. The threaded shaft is turned down in the threadedbore to engage the control wire to secure the control wire firmly in theretaining tube.

The threaded shaft 114 extends upwardly from the retaining tube 120through the proximal handle body 111 and is movable within the guidingslot 121. The control knob 113 is threaded onto the threaded shaft,wherein the control knob can be turned down and tightened onto theproximal handle body, thereby locking the retaining tube and controlwire 91 in a fixed position relative to the balloon catheter. When thecontrol knob is loosened, any longitudinal movement of the control knobcauses corresponding movement of the distal capsule assembly 90.

As shown in FIGS. 1 and 5, the capsule catheter assembly 52 consists ofa proximal capsule catheter assembly 130 secured to the distal end of aflexible elongate tubular member 131 formed of a suitable plasticmaterial such as polyether block amide available under the trademark"PEBAX", available from Atochem Polymers, Glen Rock, N.J. The capsulecatheter elongate tubular member is of a suitable length as, forexample, 40 to 100 centimeters and preferably approximately 60centimeters for the abdominal aortic artery and approximately 80centimeters for the thoracic aortic artery. The elongate tubular memberhas a preferred outside diameter of 0.187 inches (4.75 mm) and an insidediameter of 0.125 inches (3.175 mm). The elongate tubular member can beproduced in a certain color such as blue. To render the elongate tubularmember radiopaque under x-rays, its material of construction may containa radiopaque material, such as twenty percent by weight of bismuthsubcarbonate or barium sulfate. The elongate tubular member may havemarkings or bands distal of the wye adapter 145 at predeterminedpositions to indicate capsule jacket retraction and locking points.

The proximal catheter assembly 130 has a proximal capsule 132 mounted onthe distal extremity of the capsule catheter elongate tubular member131. The proximal capsule has a preferred diameter ranging from four tonine millimeters, which may be configured to accommodate different sizegrafts. The proximal capsule is configured to match the size of thedistal capsule assembly 90. Thus, the proximal capsule is preferablymade of stainless steel or similar impermeable and rigid, orsemi-flexible material. The elongate tubular member also serves as ashaft for advancing the proximal capsule, as hereinafter described.Thus, the elongate tubular member should have a diameter which is lessthan that of the proximal capsule, preferably having an outside diameterranging from three to seven millimeters.

Referring to FIG. 8, the proximal capsule 132 is secured to the distalextremity of the elongate tubular member 131 by means of a capsuleadapter assembly 133. The capsule adapter assembly comprises a housing134 and an inner sleeve 135, which may be constructed frompolycarbonate. The capsule adapter housing distal extremity 136 issecured in the proximal extremity of the capsule, for example, bycrimping, by using a press fit swaging or an adhesive such as acyanoacrylate ester. The capsule adapter housing distal extremity may beangled to facilitate securing the housing to the proximal capsule.

The proximal extremity of the capsule adapter housing 134 is secured tothe distal extremity of the elongate tubular member 131 by means of ancyanoacrylate ester adhesive, or other suitable means. To facilitate amechanical lock, the elongate tubular member distal extremity is moldedto form a flange 137, wherein the capsule adapter housing is configuredso as to close around the flange. The capsule adapter housing is furtherprovided with a recess for receiving the capsule adapter inner sleeve135. The inner sleeve is provided with a bore of a suitable diameter soas to allow the balloon catheter shaft 61 to reside therein. The innersleeve may further be provided with radiopaque marker rods or flatribbon 138 for detection of the capsule adapter assembly 130 duringfluoroscopy.

A wye adapter 145 is secured to the proximal extremity of the flexibletubular member 131 of the capsule catheter. The central arm 146 of thewye adapter is connected to a Touhy Borst adapter 147 which tightensaround the guiding member 115 disposed in the central arm of the wyeadapter. The side arm 148 of the wye adapter has a stop cock 149 mountedtherein which is movable between open and closed positions. The stopcock is provided with a Luer fitting 150 which is configured to accept asyringe for injecting a dye. Air may be purged from the capsule jacketassembly 53 by injecting fluid through the Luer fitting. The injectionfluid will exit purge ports 151 and 152, thereby filling the capsulejacket assembly with injection fluid. The Luer fitting may be attachedto a saline drip line during the operative procedure.

Referring to FIGS. 1, 6 and 8, the capsule jacket assembly 53 isslidably disposed coaxially over the capsule catheter assembly 52 andthe balloon catheter assembly 51. The capsule jacket assembly iscomprised of a main sheath 160, a capsule jacket support sheath 161 anda locking connector 162. The main and support sheaths are coaxial fromtheir proximal end, to a point approximately 15 centimeters from thedistal end 163 of the main sheath, depending on the length of the graft.At the point where the support sheath terminates, the main sheath flaresto an expanded diameter to cover the proximal capsule 132 and the distalcapsule 93. The diameter of the main sheath is about 0.263 inches (6.68mm) at its proximal end and about 0.3 inches (7.62 mm) at the distal end163. The proximal ends of the sheaths may be secured to the sheathadapter 164 of the locking connector by mechanical means and byadhesive. The distal end of the main sheath of the capsule jacket isprovided with radiopaque marker 166.

When the capsule jacket assembly 53 is in its most distal position, thedistal end 163 of the capsule jacket main sheath extends to cover atleast a portion of the distal capsule assembly 90. Similarly, thecapsule jacket locking connector 162 is thereby positioned just proximalthe proximal capsule catheter purge port 151. Prior to insetion into thelumen, locking ring 165 is turned down to hold the capsule jacketassembly firmly in place, thereby maintaining a smooth transitionsurface along the length of the intraluminal grafting system 50 whichresides in the body vessels. When the locking ring is released, thecapsule jacket assembly may be moved to a furthermost proximal position,wherein at least a portion of the proximal capsule catheter assembly isexposed. Thus, the locking connector is positioned just distal thecapsule catheter wye adapter 145. The locking ring may be tightened atany intermediate position to firmly secure the capsule jacket assemblyat the desired location. In addition, a radiopaque marker 166 isprovided at the distal end of the main sheath to facilitate properlinear positioning of the main sheath.

As shown in FIGS. 1 and 7, the intraluminal grafting apparatus 50 alsoincludes an expandable intraluminal vascular graft 55 for implanting ina body vessel. Referring to FIG. 23, the graft consists of a deformabletubular member 170 which is provided with superior end 171, inferior end172 and a cylindrical or continuous wall 173 extending between thesuperior and inferior ends of the graft. The tubular member may have alength in the range of 8 to 20 centimeters, where 10 centimeters issuitable for most patients. The tubular member may have a maximumexpandable diameter ranging from 14 to 40 millimeters and a minimumdiameter in a collapsed condition of 0.175 to 0.3 inches (4.44-7.62 mm).The continuous wall can be woven of any surgical implantable materialsuch as polytetrafluroethylene or a polyester fiber made frompolyethylene terephthalate (PET), such as "DACRON" type 56. One materialfound to be satisfactory is "DEBAKEY" soft woven "DACRON" vascularprosthesis (uncrimped) sold by C. R. Bard of Billerica, Mass. In orderto prevent unraveling of the woven material at the ends, the ends can bemelted with heat to provide a small melted bead of material on each end.

Referring to FIG. 23, expandable attachment means 175 is securedadjacent the superior end 171 of the tubular member 170. Similarly,expandable attachment system 176 is secured adjacent the tubularmember's inferior end 172. Each attachment system serves to yieldablyurge the tubular member from a first compressed or collapsed position toa second expanded position. Each attachment system is formed of aplurality of vees 177 with the outer apices 178 and inner apices 179 ofthe vees being formed with helical coil springs 180 to yieldably urgethe long legs 181 and short legs 182 of each of the vees outwardly at adirection approximately at right angles to the plane in which each ofthe vees lie.

As shown in more detail in FIG. 25, the superior attachment system 175is comprised of a single piece of wire which is formed to provide thevees 177 and also to define the helical coil springs 180 between thelegs 181 and 182. The two ends of the single piece of wire can be weldedtogether in one of the legs to provide a continuous spring-likeattachment means. In the construction shown in FIG. 23, it can be seenthat the attachment means have apices lying in four longitudinallyspaced-apart parallel planes which are spaced with respect to thelongitudinal axis of the tubular member 170.

The superior and inferior attachment means 175 and 176 are secured tothe superior and inferior ends 171 and 172, respectively, of the tubularmember 170 by suitable means such as a polyester suture material 190. Asshown in FIG. 23, the suture material is used for sewing the attachmentmeans onto the wall 173 of the tubular member. Knots 191 are preferablyformed on each of the legs or struts 181 and 182 to firmly secure eachleg to the graft. The legs may be secured so that the apices lying ineach plane are staggered to provide for the minimum profile when theattachment means is placed in its collapsed condition. The inferiorattachment means 176 may be attached to the inferior end of the graft172 in a similar manner.

As shown in FIGS. 25 and 26, wall engaging members 195 and 196 arepreferably secured to the legs 181 and 182 in the vicinity of the outerapices 178 by suitable means such as welding. The wall engaging membershave a diameter ranging from 0.01 to 0.018 inches (0.254-0.457 mm) and alength from 0.5 to 5.0 millimeters. The wall engaging members arepreferably sharpened to provide conical tips, and should have a lengthwhich is sufficient for the tip to penetrate into and perhaps throughthe corporeal lumen wall.

The superior attachment means 175 and the wall engaging members 195secured thereto are formed of a corrosion resistant material which hasgood spring and fatigue characteristics. One such material found to beparticularly satisfactory is "ELGILOY" which is a cobalt-chromium-nickelalloy manufactured and sold by Elgiloy of Elgin, Ill. The wire can havea diameter ranging from 0.008 to 0.016 inches (0.203-0.406 mm), with asmaller diameter wire being utilized for the smaller diameter grafts.For example, 0.012 to 0.016 inch (0.305-0.406 mm) diameter wire for theframe and wall engaging members may be used in the larger grafts ofeighteen to twenty-eight millimeters diameter, and 0.008 to 0.012 inch(0.203-0.305 mm) diameter wire may be used in the smaller grafts beingeight to sixteen millimeters in diameter.

It has been found that the spring force created by the helical coils 180at the apices 178 and 179 is largely determined by the diameter of thewire. The greater the diameter of the wire, the greater the spring forceapplied to the legs 181 and 182 of the vees. Also, the longer thedistances are between the apices, the smaller the spring force that isapplied to the legs. It therefore has been desirable to provide aspacing between the outer extremities of the legs of approximately onecentimeter, although smaller or larger distances may be utilized.

To facilitate securing the graft 55 in the corporeal lumen, the wallengaging members 195 and 196 of the superior attachment means 175 andinferior attachment means 176 may be angled with respect to longitudinalaxis of the tubular member 170. The wall engaging members face outwardlyfrom the tubular member to facilitate holding the graft in place.Preferably, the wall engaging members on the superior attachment meansare inclined from the longitudinal axis and toward the inferior end ofthe graft 172 by 55° to 85° and preferably about 75°. Likewise, the wallengaging members of the inferior attachment means may be inclinedtowards the superior end of the graft 175 by 30° to 90° and preferably85°. By angling the wall engaging members so that they resist the forceof the blood flow, the implanted wall engaging members oppose migrationof the graft.

The helical coil springs 180 placed at the apices 178 and 179 serve tofacilitate compression of the graft 55 to place the superior andinferior attachment means 175 and 176 within the capsule assemblies 90and 130, as hereinafter described. The compression of the graft isaccomplished by deformation of the coil springs within their elasticlimits. Placing the apices in different planes and staggering oroffsetting the wall engaging members 195 and 196 significantly reducesthe minimum compressed size of the graft. Having the apices in differentplanes also helps to prevent the wall engaging members from becomingentangled with each other. The natural spring forces of the helical coilsprings serves to expand the graft to its expanded position as soon asthe attachment means is free of the capsule means.

The graft 55 preferably contains radiopaque marker means for locatingthe graft and for detecting any twisting of the graft during deployment.The radiopaque marker means takes the form of two sets of radiopaquemarkers 197 and 198. The radiopaque markers are made of a suitablematerial such as a platinum tungsten alloy wire of a suitable diametersuch as 0.004 inches (0.102 mm) which is wound into a spring coil havinga diameter of 0.04 inches (0.102 mm). The radiopaque markers are securedto the tubular member 170 by sutures 199, using the same material suedto secure the attachment means to the graft.

As shown in FIG. 23, the radiopaque markers 197 and 198 are located onthe tubular member 170 of the graft 55 in a line parallel to thelongitudinal axis of the tubular member. Each tubular member preferablyhas at least two sets of markers such that the first marker ispositioned 0.5 centimeters from the superior attachment system 175.Additional markers are positioned every one centimeter thereafter forthe length of the tubular member. The last marker in each set is 0.5centimeters away from the inferior attachment system 176. Thus, thetotal number of markers in each set depends upon the length of thegraft.

Referring also to FIG. 24, each of the first set of radiopaque markers197 has a preferred length of 3 millimeters. Each of the second set ofmarkers 198 preferably has a smaller length, for example 2 millimeters,and are positioned along the longitudinal axis of the tubular member 170at a position 180° from the first set of markers. By placing markers ofdifferent lengths along the axis of the tubular member, it is possibleto ascertain the position of the graft 55 and to determine whether thegraft has twisted between its superior and inferior ends 171, 172. Underfluoroscopy, the two sets markers will be exhibited as two relativelystraight lines for an untwisted graft, wherein a twisted graft will berevealed by a non-linear pattern of markers. By placing the markers atequal increments apart, it is possible to use fluoroscopy to ascertainlongitudinal compression or tension on the graft.

The sizing of the graft 55 may be performed on a patient-by-patientbasis, or a series of sizes may be manufactured to adapt to most patientneeds. For the repair of an aortic aneurism, the length of the graft isselected so to span approximately one centimeter superior and onecentimeter inferior of the aneurysm, wherein the wall engaging members195 and 196 of the graft can seat within normal tissue of the vessel onboth sides of the aneurysm. Thus, the graft should be about twocentimeters longer than the aneurysm being repaired. During thepreimplant fluoroscopy procedure, a conventional pigtail catheter isused to determine the locations of the renal arteries to ensure therenals will not be covered by the implanted graft. Similarly, thediameter of the tubular member 170 is selected by measuring thecorporeal lumen which will receive the graft by conventionalradiographic techniques and then selecting a tubular member having adiameter one millimeter larger than that measured.

FIG. 8 depicts the distal end of the intraluminal grafting system 50assembled for deployment. The graft 55 is disposed within the proximalcapsule assembly 130, the distal capsule assembly 90 and the capsulejacket assembly 53. The superior end of the graft 171 and superiorattachment means 175 are removably retained within the distal capsule93. Likewise, the inferior end of the graft 172 and inferior attachmentmeans 176 are removably retained within the proximal capsule 132. Thedistal cap 92 is in its retracted or proximal position adjacent toproximal cap 100. Similarly, core wire 91 is locked via control knob 113in its retracted or proximal position. During initial deployment,capsule catheter tubular member 131 is in its most distal position inrelation to balloon catheter assembly 51 and is locked in place by thelocking ring on the Touhy Borst adapter 147.

During initial deployment, the distal end of the balloon catheter 80 ispositioned such that the balloon 60 resides within the tubular member170 of the graft 55, as shown in FIG. 8. The proximal cap 100 ispositioned just proximal the distal cap 92 and is disposed within thedistal capsule 93. Likewise, pusher button 85 is disposed just proximalthe inferior attachment means 176 of the graft. The capsule jacketassembly 53 is positioned such that the distal end of the capsule jacketmain sheath 160 overlaps at least a portion of the distal capsule 93.During deployment, capsule jacket locking connector 162 secures the mainsheath in place. Thus, when any movement or force is applied to thehandle assembly 110, the entire apparatus 50 moves as a single unit.

By way of example, the following describes a method of repair of anaortic aneurism using the method comprising the present invention forintraluminal placement of a graft in an aorta. First, a patient isprepared in a conventional manner by use of a guide wire 56, a dilatorand sheath (not shown) to open the femoral artery or vessel of thepatient. The distal end of the intraluminal grafting apparatus 50 isthen inserted into the sheath, which has previously been placed in thefemoral artery. In the preferred embodiment of the present invention,balloon catheter lumen 63 is provided for receiving the guide wire 56.However, the following procedure may also be used when the guidingmember is constructed as part of the balloon catheter.

As shown in FIG. 27, the guide wire 56 is introduced by the physicianinto the femoral artery and advanced to the desired location in theaorta 200 and adjacent to the diseased or damaged portion of the vessel201. The balloon catheter assembly 51, the capsule catheter assembly 52,the capsule jacket assembly 53 and the control wire assembly 54 are allconfigured for deployment as shown in FIGS. 1 and 8. Thus, theassemblies are advanced by the physician as a single unit over the guidewire. The physician uses the handle assembly 110 and the proximal end ofthe balloon catheter 70 to guide the distal end of the assemblies overthe guide wire. Typically, the desired position for implanting the graft55 will be within the abdominal aorta with the superior extremity 171 ofthe graft at least one centimeter inferior to the lower renal artery.

When the distal capsule assembly 90 and the superior attachment means175 are in the desired position, the superior end of the graft 55 isimplanted. First, the locking ring 165 of the capsule jacket assembly 53is loosened to allow movement of the capsule jacket main sheath 160.While using one hand to firmly grasp the capsule catheter assembly 52and hold it stationary, the physician grasps the sheath adapter 164 withthe other hand and gently pulls the sheath adapter proximally towardsthe capsule catheter wye adapter 145, as shown in FIG. 28. The capsulejacket assembly is moved about 6 centimeters to fully expose the distalcapsule assembly, and partially expose the graft. The locking ring isthen tightened to hold the capsule jacket assembly in place.

At this point in the procedure, the superior end of the graft 171 isdisposed in the distal capsule 93, the inferior end of the graft 172 issecurely retained with in the proximal capsule 132 and the distal end ofthe capsule jacket main sheath 160 is located about midway between theends of the graft. The control knob 113 is then loosened to permitrelative movement between the distal capsule assembly 90 and the ballooncatheter assembly 51 to expose superior end 171 of the graft 55. Againusing one hand to firmly grasp the handle assembly 110, the physicianslides the control knob distally toward the wye adapter 145. Since thedistal cap 92 and distal capsule 93 are secured to the control wire 91,they move in a about a 1:1 ratio with the movement of the control knob.The control knob is moved distally approximately 3 centimeters, whichmoves the distal capsule from engagement with the superior attachmentmeans 175 and exposes the balloon catheter proximal cap 100. The controlknob is then locked in place. As soon as the distal capsule has clearedthe superior attachment means 175, the superior extremity of graftexpands outwardly under the force of the self-expanding attachment meanswhich springs into engagement with the vessel wall 202.

Once the superior attachment means 175 is exposed, steps are taken tofirmly seat or urge the wall engaging members 195 an 196 in the vessellumen. First, locking ring 165 is loosened, and the capsule jacketassembly 53 is moved proximally to a point where the distal end of themain sheath 160 is positioned just proximal the distal end of theproximal capsule 132 (FIG. 29). The capsule jacket assembly is thenlocked in place. Then, the locking ring on the capsule catheter TouhyBorst adapter 147 is loosened to permit relative movement between thecapsule catheter assembly 52 and the balloon catheter 51. While thephysician uses one hand to hold the capsule catheter assemblystationary, the handle assembly 110 is grasped by the other hand andpushed distally to position the center of the balloon 60 into thesuperior extremity of the graft 171. The radiopaque marker 84 is used toalign the balloon and attachment means.

Thereafter, a conventional hand operated syringe or inflation assembly(not shown) is attached to the balloon catheter inflation port 74. Theballoon is then expanded by introducing a suitable gas such as carbondioxide or a dilute radiopaque liquid from the syringe to urge the wallengaging members 195 and 196 outwardly to firmly emplace the attachmentsystem within the vessel wall 202. The balloon may be deflated andinflated repeatedly to ensure the superior attachment means is firmlyimplanted in the vessel. The balloon may be then deflated or may remainin an inflated position during the next steps of the procedure.

As shown in FIG. 30, the next step is to implant or anchor the inferiorattachment system 176. With the handle assembly 110 held firmly inplace, the capsule catheter assembly 52 is moved proximally until theinferior attachment system and inferior end of the graft 172 arecompletely clear of the proximal capsule 132. Once the inferiorextremity of the graft is free of the proximal capsule, the inferiorattachment system will spring open and the wall engaging members 195 and196 will engage the vessel wall 202. Leaving the balloon 60 inflatedwhile the capsule catheter assembly is moved ensures that the superiorattachment system 175 will remain firmly secured in place. Thereafter,the balloon may be deflated and the capsule catheter locking ring 147secured to the guiding member 115, thereby securing the capsule catheterassembly 52 to the balloon catheter assembly 51.

In certain circumstances, an alternate method of deploying the inferiorattachment system 176 may be employed. Such an alternate method may beadvantageous when a graft has been chosen that is of a length whichexceeds the length of the aorta, thereby jeopardizing a secureemplacement of the inferior extremity of the graft. In such cases, theballoon 60 is deflated so that the balloon catheter assembly 51 can befreely moved within the corporeal lumen. Next, the capsule catheterassembly 52 is advanced in a distal direction so that the inferiorattachment system is positioned in the desired location of the aorta200.

With the inferior attachment system 176 and the inferior extremity ofthe graft 172 in the portion of the corporeal lumen where the wallengaging members 196 are to engage the vessel wall 202, the ballooncatheter shaft 61 is advanced so that the pusher button 85 and retainingbump 86 engage the inferior attachment system. Then the user holds thehandle assembly 54 and balloon catheter assembly 51 fixed while movingthe capsule catheter assembly 52 in a proximal direction. When theproximal capsule assembly 130 moves sufficiently distally, the inferiorattachment system will be released from the proximal capsule 132. Theinferior attachment system and inferior wall engaging members may thenbe secured with the balloon 60.

As shown in FIG. 31, the handle assembly 110 is moved proximally so thatthe balloon 60 is then retracted further into the graft 55 and placedadjacent the inferior attachment system 176. Again, the balloonradiopaque marker 84 is used to align the center of the balloon with theattachment means. The balloon is then inflated, and perhaps deflated andinflated, to expand the attachment system and ensure that the wallengaging members 195 and 196 are firmly urged and implanted in thevessel wall 202. Thereafter, the balloon is finally deflated.

As shown in FIG. 32, the proximal capsule assembly 130 and balloon 60are moved proximal the graft 55. First the locking ring 147 is loosened.Then, while holding the capsule catheter assembly 52 in place bygrasping the wye adapter 145 with one hand, the balloon catheterassembly 51 is moved proximally by gently pulling the handle assembly110 with the other hand. Thus, the capsule catheter assembly and ballooncatheter are in the same relative position as they were just prior todeployment (FIG. 8). Also, the proximal end 103 of the distal capsule 93has been mated with the proximal cap 100 for smooth transition.

Finally, as shown in FIG. 33, the capsule jacket locking ring 165 isloosened. While holding the capsule jacket sheath adapter 164 in place,the balloon catheter and capsule catheter assemblies 51 and 52 are movedproximally and in unison by gently pulling the wye 145 of the capsulecatheter assembly. The catheter assemblies are moved until the distalend of the main sheath 163 covers the distal capsule 93 or until theproximal capsule adapter housing 134 mates with the flared transition ofthe capsule jacket, thereby creating a smooth transition along theentire length of the intraluminal grafting apparatus 50. Thereafter, theballoon catheter assembly, capsule catheter assembly, capsule jacketassembly 53 and control wire assembly 54 are removed from the aortathrough the femoral artery. The graft 50 and attachment means 175 and176 remain secured to the vessel wall 202, thereby sealing the aneurism201 from blood flow.

The entire procedure described herein can be observed under fluoroscopy.The relative positioning of the graft 55 and the balloon 60 can bereadily ascertained by the radiopaque attachment systems 175 and 176,radiopaque markers 197 and 198 provided on the graft, and the radiopaquemarker 84 on the balloon shaft 61. If any twisting of the graft hasoccurred between placement of the superior attachment system and theinferior attachment system, then the twisting can be readily ascertainedby observing the series of markers 197 and 198. Adjustments to eliminateany twisting which may have occurred can be made before exposing thegraft's inferior extremity 172 by rotation of the capsule catheterassembly 52. Any excessive graft compression can be ascertained byobserving the radiopaque markers 197 and 198 under fluoroscopy.Adjustments to eliminate graft compression can be made before exposingthe inferior extremity of the graft by applying tension on the capsulecatheter assembly 52.

Post implant fluoroscopy procedures can be utilized to confirm theproper implantation of the device by the use of a conventional pigtailcatheter or by injecting dye into the guide wire lumen of the ballooncatheter shaft. Thereafter the sheath can be removed from the femoralartery and the femoral artery closed with conventional suturingtechniques. Tissues should begin to grow into the graft within two tofour weeks with tissue completely covering the interior side of thegraft within six months so that no portion of the graft thereafter wouldbe in communication with the blood circulating in the vessel. Thisestablishes a complete repair of the aneurysm which had occurred.

While several particular forms of the invention have been illustratedand described, it will be apparent that various modifications can bemade without departing from the spirit and scope of the invention. Forexample, references to materials of construction and specific dimensionsare also not intended to be limiting in any manner and other materialsand dimensions could be substituted and remain within the spirit andscope of the invention. Accordingly, it is not intended that theinvention be limited, except as by the appended claims.

What is claimed is:
 1. A system for placing a graft in a lumen formed bya wall in a body, said system comprising:a tubular graft having asuperior extremity and an inferior extremity, said graft beingdeformable between a collapsed condition and an expanded condition;first anchoring means secured to the superior extremity of said graftfor attaching the superior extremity of said graft to the lumen wall;second anchoring means secured to the inferior extremity of said graftfor attaching the inferior extremity of said graft to the lumen wall;said first and second anchoring means each including a plurality of wallengaging members and a continuous wire frame configured to provide aplurality of vees; a distal capsule assembly for covering said firstanchoring means; a proximal capsule assembly for covering said secondanchoring means, wherein at least a portion of said graft between saidfirst and second anchoring means remains uncovered; placement means forpositioning said graft, said distal capsule assembly and said proximalcapsule assembly at a desired location in the lumen, said placementmeans including means for moving said distal capsule assembly relativeto said proximal capsule assembly to uncover said first anchoring meansand means for moving said proximal capsule assembly relative to saidgraft to uncover said second anchoring means; wherein said placementmeans includes first catheter means having a balloon secured to aflexible elongate shaft having an inflation lumen in fluid communicationwith the balloon, the first catheter means being capable of moving theballoon within said graft and into engagement with said first anchoringmeans and with said second anchoring means: wherein said distal capsuleassembly includes a distal capsule and a proximal cap slidably retainedin the distal capsule and secured on the shaft of the first cathetermeans of said placement means, wherein the shaft extends through theproximal capsule assembly, the proximal cap, and the distal capsule: anda removable sleeve of a flexible material, said removable sleeveincluding a main sheath having an expanded diameter configured to extendover said proximal capsule assembly, said graft and at least a portionof said distal capsule assembly, wherein a smooth transition is providedbetween said distal capsule assembly and said proximal capsule assembly.2. The system as recited in claim 1, wherein said placement meansincludes means for moving said proximal capsule assembly to uncover saidsecond anchoring means before said distal capsule assembly is moved touncover said first anchoring means.
 3. The system as recited in claim 1,wherein said removable sleeve further comprising means for securing saidremovable sleeve to said placement means and for manipulating saidremovable sleeve to uncover said distal capsule assembly and to uncoversaid proximal capsule assembly.
 4. The system as recited in claim 1,wherein the placement means further comprises a control wire having aproximal end and a distal end secured to the distal capsule, the shaftof the first catheter means of said placement means being provided witha control wire lumen for slidably retaining the control wire, wherebythe distal capsule moves relative to the shaft by movement of theproximal end of the control wire.
 5. The system as recited in claim 4,wherein said placement means further comprises second catheter meansincluding a flexible elongate shaft having a proximal end positioneddistal the proximal end of the shaft of said first catheter means andhaving a distal end secured to the proximal capsule assembly, such thatmovement of said second catheter means may move said proximal capsuleassembly without moving said distal capsule assembly.
 6. The system asin recited claim 5, wherein the shaft of the first catheter means ofsaid placement means is coaxially disposed within the shaft of thesecond catheter means of said placement means, said removable sleevebeing coaxially disposed over both the shaft of the first catheter meansand the shaft of the second catheter means.
 7. The system as recited inclaim 6, further comprising a guide wire, wherein the shaft of the firstcatheter means of said placement means is further provided with a guidewire lumen extending the length of the shaft for retaining said guidewire.